GSK plc (NYSE:GSK) announced headline results from a planned interim efficacy analysis of the DREAMM-7 head-to-head phase 3 trial evaluating belantamab mafodotin as a second-line treatment for relapsed or refractory multiple myeloma. 

The study included 494 patients previously treated with at least one multiple myeloma regimen.

The trial met its primary endpoint of progression-free survival (PFS) and showed that belantamab mafodotin when combined with bortezomib plus dexamethasone (BorDex), significantly extended the time to disease progression or death versus daratumumab plus BorDex, an existing standard of care for relapsed/refractory multiple myeloma. 

A strong and clinically meaningful overall survival (OS) trend with a nominal p-value < 0.0005 was also observed during this analysis. The trial continues to follow up for OS.

Belantamab mafodotin marketed as Blenrep, received FDA accelerated approval in August 2020 as a monotherapy for relapsed or refractory multiple myeloma patients who have received at least four prior therapies. 

Last year, GSK withdrew Blenrep following the FDA request based on the previously announced outcome of the DREAMM-3 Phase 3 confirmatory trial, which did not meet the FDA Accelerated Approval regulations requirements. 

In September 2023, the European Medicines Agency's human medicines committee recommended not renewing the conditional marketing authorization for Blenrep for multiple myeloma.

The DREAMM clinical development program includes the ongoing head-to-head phase 3 DREAMM-8 trial evaluating belantamab mafodotin in combination with pomalidomide and dexamethasone versus bortezomib in combination with pomalidomide and dexamethasone. Data are expected in the second half of 2024.

Price Action: GSK shares are down 0.03% at $35.80 during the premarket session on the last check Monday.